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  1. G. Bouguen1,
  2. L. Peyrin-Biroulet2,
  3. A. Buisson3,
  4. D. Lafarge4,
  5. S. Tropé5,
  6. G. Montagu6,
  7. A. Denis7,
  8. C. Habauzit7,
  9. S. Benkhalifa7,
  10. H. Marotte8
  1. 1CHU de Rennes, Maladies de l’appareil digestif, Rennes, France
  2. 2CHU de Nancy, Hépatologie gastro-entérologie, Vandoeuvre-lès-Nancy, France
  3. 3Afa Crohn Rch France, Afa Crohn Rch France, PARIS, France
  4. 4Association France Spondylarthrites, Association France Spondylarthrites, TULLE, France
  5. 5Association National de Défense contre l’Arthrite Rhumatoïde, ANDAR, Clermont l’Hérault, France
  6. 6Unknowns, Unknowns, PARIS, France
  7. 7Celltrion Healthcare France, Medical, Issy Les Moulineaux, France
  8. 8CHU de Saint-Etienne, Rhumatologie, Saint-Etienne, France


Background Patients experience may be negatively impacted when starting biosimilar due to a poorly executed switch which could result in poor adherence and nocebo effect.

Objectives This study aims to identify suitable patient satisfaction dimensions to design an observational study on real-life switches.

Methods A qualitative exploratory study was performed. In-depth, semi-structured interviews were conducted by a sociologist with patients with inflammatory diseases treated by anti-TNF biosimilar to determine patient switching experiences and expectations, identify dimensions for the observational study’s questionnaire (ePRO). Patients were recruited with the help of patients’ associations.

Results Four patients (3 females) were included: 2 with rheumatoid arthritis and 2 with Crohn’s disease. Two patients had adalimumab biosimilar, 1 etanercept biosimilar and 1 adalimumab originator (switch-back). The following dimensions were identified:

Information transparency: patients were unfamiliar with biosimilars and some did not know they were using them. Some reported distrusting biosimilars but accepted them because they trust their physician.

Patient Involvement: physicians decide whether to offer a biosimilar, but patient acceptance is determined by their interpretation of the situation. Patients found it difficult to express their treatment preferences and reported that physicians didn’t always prompt these discussions.

The time of injection: patients had to learn the injection procedures but received relatively little support during the switch in handling the new device. Some experienced greater pain, differences in comfort or reported errors in use.

● Transition: the sustainability of the switch may have been constrained by delays in supply in the city. In some cases, the pharmacy dispensed the originator drug as a replacement.

These led to the following ePRO composition: BMQ, HLSEU-Q16 (health literacy), ad hoc items on shared decision making, expectations, patient training, satisfaction with provided information and injection. All 4 patients understood the final questionnaire.

The study design is an open label multicentric study of 300 patients in 30 sites (rheumatology and gastroenterology, hospital, and private practice) when offered a switch. The primary objective is to assess patients’ overall satisfaction with injections 3 months post-initiation compared to the previous adalimumab. The first patient was included in June 2022.

Conclusion This work proposes an original methodology for the selection and design of criteria for an observational study. An exploratory qualitative study highlighted different factors of patient satisfaction during the switch to adalimumab biosimilar. It guided the choice of e-PROs and the construction of specific items.


Acknowledgements: NIL.

Disclosure of Interests Guillaume BOUGUEN Speakers bureau: AbbVie, Takeda, MSD, Janssen, Celltrion

, Consultant of: AbbVie, Takeda, Mylan, Pfizer, Sandoz, Amgen, Ferring, Janssen, Celltrion, Grant/research support from: AbbVie, Takeda, Fresenius

, Laurent Peyrin-Biroulet Speakers bureau: Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillotts, Pharmacosmos, Celltrion Healthcare, Takeda, Boerhinger Ingelheim, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Alma, Sterna, Nestle, Inotrem, Enterome, Allergan, MSD, Roche, Arena, Gilead, Hikma, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, Oppilan Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, Theravance

, Anne BUISSON: None declared, Delphine LAFARGE: None declared, Sonia Tropé: None declared, Guillaume Montagu: None declared, Alice DENIS Shareholder of: Celltrion Healthcare France, Employee of: Celltrion Healthcare France, Caroline HABAUZIT Shareholder of: Celltrion Healthcare France, Employee of: Celltrion Healthcare France, salim benkhalifa Shareholder of: Celltrion Healthcare France, Employee of: Celltrion Healthcare France, Hubert MAROTTE Shareholder of: AbbVie, Amgen, Bristol Myers Squibb, Celltrion HealthCare, Galapagos, Lilly France, Merck Sharp & Dohme, Novartis, Nordic Pharma, Pfizer, and Sanofi Aventis

, Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Celltrion HealthCare, Galapagos, Lilly France, Merck Sharp & Dohme, Novartis, Nordic Pharma, Pfizer, and Sanofi Aventis

, Grant/research support from: Bristol Myers Squibb, Celltrion HealthCare, Galapagos, Lilly France, Novartis, Nordic Pharma, Pfizer, and Sanofi Aventis.

  • Patient reported outcomes
  • Quality of life
  • bDMARD

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